All medical devices supplied in Australia must meet the relevant Essential Principles for safety and performance. These requirements include information provided with the device, such as labels, instructions for use and patient information materials.
Labelling requirements
Guidance on the information that must accompany medical devices and how to meet regulatory requirements.
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Labelling medical devices to meet regulatory requirements
Guidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities. -
Supplying or manufacturing medical devices containing poisons
Guidance on requirements for supplying or manufacturing medical devices containing poisons in Australia, including compliance with the Poisons Standard, labelling obligations, and safety and performance requirements.
Instructions for use
Guidance on how information and instructions can be provided to users of medical devices.
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Understanding regulation of off-label use of medical devices
Guidance on the use of a medical device in a way that is not included in the intended purpose in the Australian Register of Therapeutic Goods (ARTG), and rules for advertising off-label uses. -
Supplying electronic instructions for use (eIFU) for medical devices
Guidance for manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format.
Patient information and device identification
Information provided to patients helps support informed decision-making, device traceability and ongoing safety monitoring.
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Providing patient information leaflets and implant cards for medical devices
Guidance on how to provide the required patient information materials with all implantable and active implantable medical devices. -
Unique Device Identification (UDI) hub
A collection of information about the implementation of medical devices Unique Device Identification (UDI).
Product types